510(k) Report

Devices descending from K964736

979 later devices reach Bergen 610 Bipolar Coagulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K974521Vnus Closure SystemVnus Medical Technologies, Inc.1998977—
+1K972299Bergen Model 500 Electrosurgery GeneratorBergen Mfg.1997978—
+2K072126Habib VesealEmcision, Ltd.20070—
+2K061544Stellartech 100 Coagulation SystemStellartech Research Corp.20060—
+2K023624SLT Venous Fiber Delivery Systems, Model…Surgical Laser Technologies, Inc.20032—
+2K014251Ntero Hotrod SystemNtero Surgical, Inc.20020—
+2K012398Diomed 15 Diode LaserDiomed, Ltd.2002714—
+2K982816Vnus Closure SystemVnus Medical Technologies, Inc.1999973—
+3K070353Kelsey Intersitital Laser Therapy SystemKelsey, Inc.20071—
+3K052003Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model RFX-6-XX (XX =…Vnus Medical Technologies, Inc.20055—
+3K051996Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd.200589—
+3K041957Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc.20042971
+3K040921Cooltouch, Model NS 160Cooltouch, Inc.2004204—
+3K040638Vnus Radiofrequency Generator, Model RFG2Vnus Medical Technologies, Inc.200410—
+3K033547Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc.20046—
+3K030654Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc.200311
+3K030557Modification to Vnus Closure SystemVnus Medical Technologies, Inc.200321—
+3K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Dornier Medtech America, Inc.2002695—
+3K022266Aurora SRSyneron Medical, Ltd.2002705—
+4K243701AuroLase® SystemNanospectra Biosciences, Inc.20250—
+4K232505Endovenous Radiofrequency Generator, Endovenous Radiofrequency CatheterZhejiang Curaway Medical Technology Co., Ltd.20240—
+4K222997VVR Generator systemStarmed Co., Ltd.20230—
+4K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF…Venclose, Inc.202121
+4K181044400um Perforator and Accessory Vein Ablation KitAngioDynamics, Inc.20180—
+4K173214NES Reprocessed RF Stylet (RFS)Northeast Scientific, Inc. (Nes)20180—
+4K160754Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)Venclose, Inc.201632
+4K160639Electrosurgical Generator ESG-200Olympus Winter & Ibe GmbH20160—
+4K160392Novilase Laser Therapy System, Model LTS-2Novian Health, Inc.20160—
+4K141858Closurerfg Radiofrequency GeneratorCovidien20142—
+4K093502Vari-Lase Endovenous Laser ConsoleVascular Solutions, Inc.20100—
+4K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+4K073427Medilas D Family LasersDornier Medtech America, Inc.200881—
+4K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K073464Angiodynamics, Inc., Nevertouch II 400UM Fiber and Venacure Procedure KitAngioDynamics, Inc.20080—
+4K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+4K070536Medilas D Family LasersDornier Medtech America, Inc.2007197—
+4K063828Diomed Delta 25Diomed, Ltd.20075—
+4K062822Vari-Lase Endovenous Laser Console, Model 7500Vascular Solutions, Inc.2006132—
+4K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+4K061373Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100Vnus Medical Technologies, Inc.2006132
+4K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+4K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+4K032805Modification to Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc.20030—
+4K031489PitangaSyneron Medical, Ltd.20030—
+4K031993Aurora SRSyneron Medical, Ltd.2003303—
+4K030426Omnilux RedPhoto Therapeutics Limited2003563—
+4K030186Polris LVSyneron Medical, Ltd.2003680—
+5K253918Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)F Care Systems USA, LLC20260—
+5K250688Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency…Acotec Scientific Co., Ltd.20250—
+5K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)Venclose, Inc.20250—
+5K250068Venclose digiRF Generator (VCRFG1)Venclose, Inc.202511
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K223488ClosureFast™ Endovenous Radiofrequency Ablation CatheterMedtronic, Inc.20230—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K191073Vein360 Endovenous Radiofrequency Ablation (RFA) CatheterVein 360, LLC20190—
+5K181510Echolaser X4El.En Electronic Engineering Spa20183—
+5K162851eLyx-PROIntelligent Sensory Concept SA20170—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K150336Photonica ProfessionalWard Photonics, LLC20157—
+5K134017GigalaserPowermedic Aps20141—
+5K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+5K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+5K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+5K120460SmartluxMedmix Co., Ltd.201218—
+5K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+5K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K110375Blueshine's Gold SeriesBlueshine Srl20124—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K111887Closurefast Radiofrequency CatheterCovidien20116—
+5K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K092734E-Light LineEspansione Marketing S.P.A20102—
+5K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K090661Nes Reprocessed Varicose Vein RF CatheterNortheast Scientific, Inc.20100—
+5K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+5K090762LEDAQuantel Derma GmbH200946—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+5K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+5K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+5K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+5K073000LumaprobeClareblend, Inc.20080—
+5K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+5K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+5K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+5K080104Vari-Lase Endovenous Laser Console, Model 7542Vascular Solutions, Inc.20080—
+5K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+5K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+5K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+5K070388Profile Multi-Platform SystemSciton, Inc2007129—
+5K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+5K060792IllumimedPhotoactif, LLC2006115—